Do Physicians Have a Duty to Support Secondary Use of Clinical Data in Biomedical Research? An Inquiry into the Professional Ethics of Physicians.

Secondary use of clinical data in research or learning activities (SeConts) has the potential to improve patient care and biomedical knowledge. Given this potential, the ethical question arises whether physicians have a professional duty to support SeConts. To investigate this question, we analyze prominent international declarations on physicians' professional ethics to determine whether they include duties that can be considered as good reasons for a physicians' professional duty to support SeConts. Next, we examine these documents to identify professional duties that might conflict with a potential duty of physicians to support SeConts.

Prioritization and Resource Allocation in the Context of the COVID-19 Pandemic: Recommendations for Colorectal and Pancreatic Cancer in Germany.

In the context of the COVID-19 pandemic, there has been a scarcity of resources with various effects on the care of cancer patients. This paper provides an English summary of a German guideline on prioritization and resource allocation for colorectal and pancreatic cancer in the context of the pandemic. Based on a selective literature review as well as empirical and ethical analyses, the research team of the CancerCOVID Consortium drafted recommendations for prioritizing diagnostic and treatment measures for both entities. The final version of the guideline received consent from the executive boards of nine societies of the Association of Scientific Medical Societies in Germany (AWMF), 20 further professional organizations and 22 other experts from various disciplines as well as patient representatives. The guiding principle for the prioritization of decisions is the minimization of harm. Prioritization decisions to fulfill this overall goal should be guided by (1) the urgency relevant to avoid or reduce harm, (2) the likelihood of success of the diagnostic or therapeutic measure advised, and (3) the availability of alternative treatment options. In the event of a relevant risk of harm as a result of prioritization, these decisions should be made by means of a team approach. Gender, age, disability, ethnicity, origin, and other social characteristics, such as social or insurance status, as well as the vehemence of a patient's treatment request and SARS-CoV-2 vaccination status should not be used as prioritization criteria. The guideline provides concrete recommendations for (1) diagnostic procedures, (2) surgical procedures for cancer, and (3) systemic treatment and radiotherapy in patients with colorectal or pancreatic cancer within the context of the German healthcare system.

Physicians' attitudes towards secondary use of clinical data for biomedical research purposes in Germany. Results of a quantitative survey.

BACKGROUND: For biomedical data-driven research purposes, secondary use of clinical data carries great but largely untapped potential. Physicians' attitudes and their needs towards secondary data use are essential to inform its practical and ethically sound implementation but are currently understudied. OBJECTIVE: Therefore, the objectives of the study are to assess physicians' (i) general attitudes and concerns, (ii) willingness to adapt workflows and to make data available for secondary use, (iii) group-specific conditions toward implementation of secondary use and associated concerns of physician-scientists and purely clinical physicians. METHODS: We developed an online survey based on a literature review and an expert interview study. Physicians in private practice and at two large German university hospitals were surveyed from May 2021 until January 2022. RESULTS: In total, 446 physicians participated in the survey. 96% [380/397] of all physicians reported a positive attitude towards secondary use; 87% [31/397] are in-principle willing to support secondary use of clinical data along with a small proportion of physicians with fundamental reservations. Secondly, the most important conditions for adapting workflows were funding of additional time and effort for research-adequate documentation (71% [286/390]) and the most important condition for providing patients' clinical data was reliable protection of patients' privacy (67% [254/382]). Thirdly, physician-scientists were more likely than purely clinical physicians to request additional funding for research-adequate documentation as a precondition for support (83% vs 69%, P = .002) and the privilege to conduct research with their own patients' clinical data before other researchers are allowed to (43% vs 11%, P < .001); while purely clinical physicians more frequently require reliable protection of patient privacy (76% vs 62%, P = .007) and monetary compensation (45% vs 25%, P < .001). CONCLUSION: Since this study presents high in-principle willingness of physicians to support secondary use along with little general concerns, it seems essential to address physicians' group-specific conditions toward secondary use in order to gain their support.

UNCAN.eu: Toward a European Federated Cancer Research Data Hub.

To enable a collective effort that generates a new level of UNderstanding CANcer (UNCAN.eu) [Cancer Discov (2022) 12 (11): OF1], the European Union supports the creation of a sustainable platform that connects cancer research across Member States. A workshop hosted in Heidelberg gathered European cancer experts to identify ongoing initiatives that may contribute to building this platform and discuss the governance and long-term evolution of a European Federated Cancer Data Hub.

Comparative ethical evaluation of epigenome editing and genome editing in medicine: first steps and future directions.

Targeted modifications of the human epigenome, epigenome editing (EE), are around the corner. For EE, techniques similar to genome editing (GE) techniques are used. While in GE the genetic information is changed by directly modifying DNA, intervening in the epigenome requires modifying the configuration of DNA, for example, how it is folded. This does not come with alterations in the base sequence ('genetic code'). To date, there is almost no ethical debate about EE, whereas the discussions about GE are voluminous. Our article introduces EE into bioethics by translating knowledge from science to ethics and by comparing the risks of EE with those of GE. We, first (I), make the case that a broader ethical debate on EE is due, provide scientific background on EE, compile potential use-cases and recap previous debates. We then (II) compare EE and GE and suggest that the severity of risks of novel gene technologies depends on three factors: (i) the choice of an ex vivo versus an in vivo editing approach, (ii) the time of intervention and intervention windows and (iii) the targeted diseases. Moreover, we show why germline EE is not effective and reject the position of strong epigenetic determinism. We conclude that EE is not always ethically preferable to GE in terms of risks, and end with suggestions for next steps in the current ethical debate on EE by briefly introducing ethical challenges of new areas of preventive applications of EE (III).

Patient data for commercial companies? An ethical framework for sharing patients' data with for-profit companies for research.

BACKGROUND: Research using data from medical care promises to advance medical science and improve healthcare. Academia is not the only sector that expects such research to be of great benefit. The research-based health industry is also interested in so-called 'real-world' health data to develop new drugs, medical technologies or data-based health applications. While access to medical data is handled very differently in different countries, and some empirical data suggest people are uncomfortable with the idea of companies accessing health information, this paper aims to advance the ethical debate about secondary use of medical data generated in the public healthcare sector by for-profit companies for medical research (ReuseForPro). METHODS: We first clarify some basic concepts and our ethical-normative approach, then discuss and ethically evaluate potential claims and interests of relevant stakeholders: patients as data subjects in the public healthcare system, for-profit companies, the public, and physicians and their healthcare institutions. Finally, we address the tensions between legitimate claims of different stakeholders in order to suggest conditions that might ensure ethically sound ReuseForPro. RESULTS: We conclude that there are good reasons to grant for-profit companies access to medical data if they meet certain conditions: among others they need to respect patients' informational rights and their actions need to be compatible with the public's interest in health benefit from ReuseForPro.

Ethics of the fiduciary relationship between patient and physician: the case of informed consent.

This paper serves two purposes: first, the proposition of an ethical fiduciary theory that substantiates the often-cited assertion that the patient-physician relationship is fiduciary in nature; and second, the application of this theory to the case of informed consent. Patients' decision-making preferences vary significantly. While some seek fully autonomous decision-making, others prefer to delegate parts of their decision. Therefore, we propose an ethical fiduciary theory that allows physician and patient to jointly determine the physician's role on a spectrum from fiduciary as advisor to fiduciary as agent. Drawing on legal concepts of the fiduciary relationship and on phenomenological accounts of obligation by Lévinas and Løgstrup, our theory relies on the key attributes of trust, vulnerability and otherness. Finally, practical implications of this theory for the informed consent process are developed: we propose a preassessment of patients' risk and value profiles as well as a restructuring of the oral consent interview and the written consent materials.

Neither carrots nor sticks? Challenges surrounding data sharing from the perspective of research funding agencies-A qualitative expert interview study.

BACKGROUND: Data Sharing is widely recognised as crucial for accelerating scientific research and improving its quality. However, data sharing is still not a common practice. Funding agencies tend to facilitate the sharing of research data by both providing incentives and requiring data sharing as part of their policies and conditions for awarding grants. The goal of our article is to answer the following question: What challenges do international funding agencies see when it comes to their own efforts to foster and implement data sharing through their policies? METHODS: We conducted a series of sixteen guideline-based expert interviews with representatives of leading international funding agencies. As contact persons for open science at their respective agencies, they offered their perspectives and experiences concerning their organisations' data sharing policies. We performed a qualitative content analysis of the interviews and categorised the challenges perceived by funding agencies. RESULTS: We identify and illustrate six challenges surrounding data sharing policies as perceived by leading funding agencies: The design of clear policies, monitoring of compliance, sanctions for non-compliance, incentives, support, and limitations for funders' own capabilities. However, our interviews also show how funders approach potential solutions to overcome these challenges, for example by coordinating with other agencies or adjusting grant evaluation metrics to incentivise data sharing. DISCUSSION AND CONCLUSION: Our interviews point to existing flaws in funders' data sharing policies, such as a lack of clarity, a lack of monitoring of funded researchers' data sharing behaviour, and a lack of incentives. A number of agencies could suggest potential solutions but often struggle with the overall complexity of data sharing and the implementation of these measures. Funders cannot solve each challenge by themselves, but they can play an active role and lead joint efforts towards a culture of data sharing.

Patients' Willingness to Provide Their Clinical Data for Research Purposes and Acceptance of Different Consent Models: Findings From a Representative Survey of Patients With Cancer.

BACKGROUND: Secondary use of clinical data for biomedical research purposes holds great potential for various types of noninterventional, data-driven studies. Patients' willingness to support research with their clinical data is a crucial prerequisite for research progress. OBJECTIVE: The aim of the study was to learn about patients' attitudes and expectations regarding secondary use of their clinical data. In a next step, our results can inform the development of an appropriate governance framework for secondary use of clinical data for research purposes. METHODS: A questionnaire was developed to assess the willingness of patients with cancer to provide their clinical data for biomedical research purposes, considering different conditions of data sharing and consent models. The Cancer Registry of the German federal state of Baden-Württemberg recruited a proportionally stratified random sample of patients with cancer and survivors of cancer based on a full census. RESULTS: In total, 838 participants completed the survey. Approximately all participants (810/838, 96.7%) showed general willingness to make clinical data available for biomedical research purposes; however, they expected certain requirements to be met, such as comparable data protection standards for data use abroad and the possibility to renew consent at regular time intervals. Most participants (620/838, 73.9%) supported data use also by researchers in commercial companies. More than half of the participants (503/838, 60%) were willing to give up control over clinical data in favor of research benefits. Most participants expressed acceptance of the broad consent model (494/838, 58.9%), followed by data use by default (with the option to opt out at any time; 419/838, 50%); specific consent for every study showed the lowest acceptance rate (327/838, 39%). Patients expected physicians to share their data (763/838, 91.1%) and their fellow patients to support secondary use with their clinical data (679/838, 81%). CONCLUSIONS: Although patients' general willingness to make their clinical data available for biomedical research purposes is very high, the willingness of a substantial proportion of patients depends on additional requirements. Taking these perspectives into account is essential for designing trustworthy governance of clinical data reuse and sharing. The willingness to accept the loss of control over clinical data to enhance the benefits of research should be given special consideration.

Sequential Geriatric Assessment in Older Patients with Colorectal Cancer during Chemotherapy: Subgroup Analysis of a Prospective, Multicenter Study EpiReal 75.

INTRODUCTION: Colorectal cancer (CRC) is a disease of older patients, but evidence-based guidelines for chemotherapy in older patients are scarce. Geriatric assessment (GA) evaluates a patient's functional status (FS) and helps in decision-making when choosing chemotherapy for older patients. However, the change of FS during chemotherapy is rarely studied as GA is mostly performed once instead of sequentially. METHODS: We performed a subgroup analysis of a prospective, multicenter study EpiReal 75. Patients aged ≥75 years with gastrointestinal malignancy prior to initiation of chemotherapy or receiving palliative chemotherapy were screened. We defined geriatric core assessments including the Eastern Cooperative Oncology Group score, Barthel's activities of daily living (ADL) scale, Lawton's instrumental activities of daily living (IADL) scale, and G-8 questionnaire, which were performed at baseline and repeated every 3 months. Quality of life (QoL) assessed by QLQ-C30 questionnaire was also re-evaluated every 3 months. We defined any deterioration in any of the geriatric parameters as unstable in the corresponding function. RESULTS: 28 patients with CRC were enrolled between April 2014 and December 2018. 20 patients were evaluable for statistical analysis with a mean age of 78.5 years (range, 75-88). Most patients received chemotherapy in palliative setting. During 3 months of chemotherapy, 25% of patients became more dependent as measured by ADL or IADL. During a median follow-up of 15 months, patients with unstable ADL or IADL had a significantly shorter overall survival (OS) than those with stable ADL or IADL (plogrank = 0.0055 and 0.0253, respectively), without a significant difference in progression-free survival (PFS). Also, unstable IADL correlated with a deterioration in aspects of QoL such as role functioning and emotional functioning (p = 0.0189 and 0.0239, respectively). 20% of patients experienced treatment-related grade 3 adverse events (AEs), no grade 4-5 AEs occurred. CONCLUSION: Sequential GA revealed changes in FS in older patients with CRC receiving chemotherapy. A deterioration of FS during chemotherapy did not influence PFS but had a negative impact on OS and QoL. It is therefore important to maintain FS in older patients with cancer, and regular performance of geriatric core assessments should be encouraged in the clinical practice.

Experience of Time and Subjective Age When Facing a Limited Lifetime: The Case of Older Adults with Advanced Cancer.

OBJECTIVES: We addressed two questions: (1) Does advanced cancer in later life affect a person's awareness of time and their subjective age? (2) Are awareness of time and subjective age associated with distress, perceived quality of life, and depression? METHODS: We assessed patients suffering terminal cancer (OAC, n = 91) and older adults free of any life-threatening disease (OA, n = 89), all subjects being aged 50 years or older. RESULTS: Older adults with advanced cancer perceived time more strongly as being a finite resource and felt significantly older than OA controls. Feeling younger was meaningfully related with better quality of life and less distress. In the OA group, feeling younger was also associated to reduced depression. Perceiving time as a finite resource was related to higher quality of life in the OA group. DISCUSSION: Major indicators of an older person's awareness of time and subjective aging differ between those being confronted with advanced cancer versus controls.

Patient-Reported Financial Distress in Cancer: A Systematic Review of Risk Factors in Universal Healthcare Systems.

Financial toxicity is a side effect of cancer that results from the perceived financial distress an individual may experience in the course of the disease. The purpose of this paper is to analyse underlying factors related to subjective financial distress in high-income countries with universal healthcare coverage. A systematic literature review was conducted to identify qualitative and quantitative studies of cancer patient-reported subjective financial distress by performing a search in the databases of PubMed, PsycINFO and CINAHL up to December 2020. A qualitative synthesis was performed linking the time-dependent occurrence of risk factors to derived categories of risk factors. Out of 4321 identified records, 30 quantitative and 16 qualitative studies were eligible. Classification of risk factors resulted in eight categories with a total of 34 subcategories. Subjective financial distress is primarily determined by pre-diagnosis sociodemographic- factors as well as financial and work factors that might change during the course of the disease. The design of healthcare and social security systems shapes the country-specific degree of subjective financial distress. Further research should focus on evolving multidisciplinary intervention schemes and multidimensional instruments for subjective financial distress to account for identified risk factors in universal healthcare systems more precisely.

Nipping Diseases in the Bud? Ethical and Social Considerations of the Concept of 'Disease Interception'.

'Disease interception' describes the treatment of a disease in its clinically inapparent phase and is increasingly used in medical literature. However, no precise definition, much less an ethical evaluation, has been developed yet. This article starts with a definition of 'disease interception' by distinguishing it from other preventions. It then analyses the ethical and social implications of the concept in light of the four principles of medical ethics by Beauchamp and Childress. The term 'disease interception' refers to a form of secondary prevention applied in a short interception window intended to prevent a preclinical disease from developing further. We propose the definition 'early and targeted secondary prevention by treatment'. The ethical evaluation of the concept shows that while it promises to be beneficial, it raises a number of ethical and social challenges regarding patient autonomy and justice. In order to ensure decision-making that respects patient autonomy, commercially motivated metaphors such as 'disease interception' should make way for precise definitions. Future research should not only focus on how to detect clinically inapparent diseases but also on the ethical question, when this is justifiable and what consequences it has for the individual and society as a whole.

Secondary Use of Clinical Data in Data-Gathering, Non-Interventional Research or Learning Activities: Definition, Types, and a Framework for Risk Assessment.

BACKGROUND: The secondary use of clinical data in data-gathering, non-interventional research or learning activities (SeConts) has great potential for scientific progress and health care improvement. At the same time, it poses relevant risks for the privacy and informational self-determination of patients whose data are used. OBJECTIVE: Since the current literature lacks a tailored framework for risk assessment in SeConts as well as a clarification of the concept and practical scope of SeConts, we aim to fill this gap. METHODS: In this study, we analyze each element of the concept of SeConts to provide a synthetic definition, investigate the practical relevance and scope of SeConts through a literature review, and operationalize the widespread definition of risk (as a harmful event of a certain magnitude that occurs with a certain probability) to conduct a tailored analysis of privacy risk factors typically implied in SeConts. RESULTS: We offer a conceptual clarification and definition of SeConts and provide a list of types of research and learning activities that can be subsumed under the definition of SeConts. We also offer a proposal for the classification of SeConts types into the categories non-interventional (observational) clinical research, quality control and improvement, or public health research. In addition, we provide a list of risk factors that determine the probability or magnitude of harm implied in SeConts. The risk factors provide a framework for assessing the privacy-related risks for patients implied in SeConts. We illustrate the use of risk assessment by applying it to a concrete example. CONCLUSIONS: In the future, research ethics committees and data use and access committees will be able to rely on and apply the framework offered here when reviewing projects of secondary use of clinical data for learning and research purposes.

[Individual financial burden following a cancer diagnosis from the perspective of social services in Germany]. / Individuelle finanzielle Belastungen infolge einer Krebserkrankung aus der Perspektive von Sozialdiensten in Deutschland.

BACKGROUND: In addition to physical, psychological and social effects, economic effects and the associated financial burden of a cancer diagnosis may also gain in importance during prolonged disease progression. Counselling by social services is an important factor in coping with this burden. METHODS: People employed in social work in oncology were invited to participate in a survey. The survey comprises 16 items on the perception of financial burdens, changes in the relevance of the topic, risk factors and current counselling practice. RESULTS: 81% of the respondents reported that the financial burden arising from a cancer diagnosis is a relevant topic of consultation for at least half of the patients. For 55%, this topic has become more important in recent years, which is due to higher survival rates, an increased number of younger patients, and poorer social security and working conditions. DISCUSSION AND CONCLUSION: Despite comprehensive insurance coverage, the financial burden of cancer patients has also gained in importance in Germany and must be increasingly taken into account in everyday social service counselling. Due to numerous risk factors and complex reasons, further measures are required to enable the early identification of risk constellations and to improve the situation of those affected.

The COVID-19 Pandemic and Cancer Patients in Germany: Impact on Treatment, Follow-Up Care and Psychological Burden.

In response to the ongoing coronavirus disease 2019 (COVID-19) pandemic, governments imposed various measures to decrease the rate of disease spread, and health care policy makers prioritized resource allocation to accommodate COVID-19 patients. We conducted a cross-sectional online survey in Germany (July 2020-June 2021) to assess the frequency of changes to cancer care among cancer patients and to explore the psychological impact of the pandemic writ large. Cancer patients who contacted the Cancer Information Service (Krebsinformationsdienst, KID) of the German Cancer Research Center (Deutsches Krebsforschungszentrum, DKFZ) via email were invited to complete an online questionnaire, capturing demographics, cancer specifics (e.g., type, disease phase, primary place of treatment, etc.), and any changes to their medical, follow-up, psycho-oncological or nursing care. General level of psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS) along with face-validated items regarding worries and social isolation specific to the pandemic. In total, 13% of 621 patients reported a change to their treatment or care plan. Of those patients with changes, the majority of changes were made to follow-up care after treatment (56%), to monitoring during treatment (29%) and to psychological counseling (20%). Of the overall sample, more than half of patients (55%) reported symptoms of anxiety and 39% reported symptoms of depression. Patients with a change in cancer care were more likely to report symptoms of depression than those with no change (AOR: 2.18; 95% CI: 1.26-3.76). Concern about the pandemic affecting the quality of health care was a predictor of both anxiety (AOR: 2.76; 95% CI: 1.75-4.35) and depression (AOR: 2.15; 95% CI: 1.43-3.23). Results showed that the majority of cancer patients in our study did not experience a change in their cancer care. However, the level of anxiety and psycho-social burden of cancer patients during the pandemic was high throughout the study period. Our findings underscore the need for health care services and policy makers to assess and to attend cancer patients' medical needs, with added emphasis on patients' psychological and social well-being. This applies particularly in situations where the healthcare system is strained and prioritization is necessary.

"Often Relatives are the Key [ ]" -Family Involvement in Treatment Decision Making in Patients with Advanced Cancer Near the End of Life.

BACKGROUND: Family communication has been increasingly recognized as an important factor in decision making near the end of life. However, the role of the family in decision making is less studied in oncology settings, where most patients are conscious and able to communicate almost until dying. The aim of this study was to explore oncologists' and nurses' perceptions of family involvement in decision making about forgoing cancer-specific treatment in patients with advanced cancer. MATERIALS AND METHODS: Qualitative semistructured interviews with 22 oncologists and 7 oncology nurses were analyzed according to the grounded theory approach. The results were discussed against the background of the clinical and ethical debate on family role near the end of life. RESULTS: We could identify two approaches shared by both oncologists and nurses toward family involvement. These approaches could be partly explained by different perception and definition of the concept of patients' autonomy: (a) a patient-focused approach in which a patient's independence in decision making was the highest priority for oncologists and (b) a mediator approach with a family focus in which oncologists and nurses assigned an active role to patients' family in decision making and strived for building consensus and resolving conflicts. CONCLUSION: The main challenge was to involve family, increasing their positive influences on the patient and avoiding a negative one. Thereby, the task of both oncologists and oncology nurses is to support a patient's family in understanding of a patient's incurable condition and to identify a patient's preference for therapy. IMPLICATIONS FOR PRACTICE: This study focused on oncologists' and oncology nurses' perceptions of family involvement in decision making about treatment limitation in patients with advanced cancer who are able to communicate in a hospital setting. Oncologists and oncology nurses should be aware of both positive aspects and challenges of family involvement. Positive aspects are patients' emotional support and support in understanding and managing the information regarding treatment decisions. Challenges are diverging family preferences with regard to treatment goals that might become a barrier to advanced care planning, a possible increased psychological burden for the family. Especially challenging is involving the family of a young patient because increased attention, more time investment, and detailed discussions are needed.

Completion rate and impact on physician-patient relationship of video consultations in medical oncology: a randomised controlled open-label trial.

BACKGROUND: Mobile phone video call applications generally did not undergo testing in randomised controlled clinical trials prior to their implementation in patient care regarding the rate of successful patient visits and impact on the physician-patient relationship. METHODS: The National Center for Tumour Diseases (NCT) MOBILE trial was a monocentric open-label randomised controlled clinical trial of patients with solid tumours undergoing systemic cancer therapy with need of a follow-up visit with their consulting physician at outpatient clinics. 66 patients were 1:1 randomised to receive either a standard in-person follow-up visit at outpatient clinics or a video call via a mobile phone application. The primary outcome was feasibility defined as the proportion of patients successfully completing the first follow-up visit. Secondary outcomes included success rate of further video calls, time spent by patient and physician, patient satisfaction and quality of physician-patient relationship. FINDINGS: Success rate of the first follow-up visit in the intention-to-treat cohort was 87.9% (29 of 33) for in-person visits and 78.8% (26 of 33) for video calls (relative risk: RR 0.90, 95% CI 0.70 to 1.13, p=0.51). The most common reasons for failure were software incompatibility in the video call and no-show in the in-person visit arm. The success rate for further video visits was 91.7% (11 of 12). Standardised patient questionnaires showed significantly decreased total time spent and less direct costs for patients (Δmean -170.8 min, 95% CI -246 min to -95.5 min), p<0.0001; Δmean -€14.37, 95% CI -€23.9 to -€4.8, p<0.005) and comparable time spent for physicians in the video call arm (Δmean 0.5 min, 95% CI -5.4 min to 6.4 min, p=0.86). Physician-patient relationship quality mean scores assessed by a validated standardised questionnaire were higher in the video call arm (1.13-fold, p=0.02). INTERPRETATION: Follow-up visits with the tested mobile phone video call application were feasible but software compatibility should be critically evaluated. TRIAL REGISTRATION NUMBER: DRKS00015788.

Late decisions about treatment limitation in patients with cancer: empirical analysis of end-of-life practices in a haematology and oncology unit at a German university hospital.

BACKGROUND: Decisions to limit treatment (DLTs) are important to protect patients from overtreatment but constitute one of the most ethically challenging situations in oncology practice. In the Ethics Policy for Advance Care Planning and Limiting Treatment study (EPAL), we examined how often DLT preceded a patient's death and how early they were determined before (T1) and after (T2) the implementation of an intrainstitutional ethics policy on DLT. METHODS: This prospective quantitative study recruited 1.134 patients with haematological/oncological neoplasia in a period of 2×6 months at the University Hospital of Munich, Germany. Information on admissions, discharges, diagnosis, age, DLT, date and place of death, and time span between the initial determination of a DLT and the death of a patient was recorded using a standardised form. RESULTS: Overall, for 21% (n=236) of the 1.134 patients, a DLT was made. After implementation of the policy, the proportion decreased (26% T1/16% T2). However, the decisions were more comprehensive, including more often the combination of 'Do not resuscitate' and 'no intense care unit' (44% T1/64% T2). The median time between the determination of a DLT and the patient's death was similarly short with 6 days at a regular ward (each T1/T2) and 10.5/9 (T1/T2) days at a palliative care unit. For patients with solid tumours, the DLTs were made earlier at both regular and palliative care units than for the deceased with haematological neoplasia. CONCLUSION: Our results show that an ethics policy on DLT could sensitise for treatment limitations in terms of frequency and extension but had no significant impact on timing of DLT. Since patients with haematological malignancies tend to undergo intensive therapy more often during their last days than patients with solid tumours, special attention needs to be paid to this group. To support timely discussions, we recommend the concept of advance care planning.